Nicorette Buccomist 1 mg/puff solution for oral spray fruit mint flavor
Spain
Table of Contents
- Package Leaflet: Information for the User
- Introduction
- 1. What Nicorette BucoMist is and what it is used for
- 2. What you need to know before using Nicorette BucoMist
- 3. How to use Nicorette BucoMist
- 4. Possible adverse effects
- 5. Storage of Nicorette BucoMist
- 6. Contents of the pack and other information
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the patient
Nicorette BucoMist 1mg/dose oral spray solution, fruit mint flavour
Nicotine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine contained in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 6 months of treatment with Nicorette BucoMist.
Contents of the leaflet
- What Nicorette BucoMist is and what it is used for
- What you need to know before using Nicorette BucoMist
- How to use Nicorette BucoMist
- Possible adverse effects
- How to store Nicorette BucoMist
- Contents of the pack and other information
1. What Nicorette BucoMist is and what it is used for
Nicorette BucoMist belongs to a group of medicines used to help people stop smoking when they intend to quit or reduce tobacco consumption before stopping completely. This type of treatment is called Nicotine Replacement Therapy (NRT).
Nicorette BucoMist relieves withdrawal symptoms that occur when quitting smoking, including cigarette cravings. When nicotine from tobacco is suddenly removed from the body, various unpleasant sensations may arise, collectively known as withdrawal syndrome. Using Nicorette BucoMist can prevent or reduce withdrawal symptoms, including the urge to smoke. Its action is based on the fact that Nicorette BucoMist continues to supply the body with a small amount of nicotine for a short period of time. Nicorette BucoMist does not contain tar, carbon monoxide, or other toxins present in tobacco.
To increase the chances of successfully quitting smoking, it is important to receive advice and support.
Consult a doctor if your condition worsens or does not improve after 6 months of treatment.
2. What you need to know before using Nicorette BucoMist
Do not use Nicorette BucoMist
- If you are allergic to nicotine or to any of the other components of this medicine (listed in section 6).
- If you are under 18 years of age.
- If you have never smoked.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Nicorette BucoMist.
Talk to your doctor before starting to use this medicine if you have any of the following conditions. You may still be able to use Nicorette BucoMist, but you should consult your doctor first:
- If you have recently suffered (within the last 3 months) a heart attack or heart attack.
- If you have chest pain (angina pectoris) or rest angina.
- If you have a heart disease affecting heart rhythm or rate.
- If you have high blood pressure (hypertension) not controlled by medication.
- If you have ever had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause this type of reaction.
- If you have severe or moderate liver disease.
- If you have severe kidney disease.
- If you have diabetes.
- If you have overactivity of the thyroid gland.
- If you have a tumor of the adrenal medulla (pheochromocytoma).
- If you have stomach or duodenal ulcer.
- If you have esophagitis.
- If you have a history of epilepsy or seizures.
Non-smokers must not use Nicorette BucoMist.
Children and adolescents
Do not give this medicine to children or adolescents.
Use of Nicorette BucoMist with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking medicines containing:
theophylline for asthma
tacrine for Alzheimer's disease
clozapine for schizophrenia
ropinirole for the treatment of Parkinson's disease.
Use of Nicorette BucoMist with food and drink
Do not eat or drink while administering a spray.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
It is very important to stop smoking during pregnancy, as smoking may cause intrauterine growth retardation, premature birth, or stillbirth. Ideally, you should try to stop smoking without using any nicotine-containing medication. If you are unable to do so, you should only use Nicorette BucoMist if recommended by your general practitioner, the doctor monitoring your pregnancy, or a smoking cessation specialist.
Breast-feeding
The use of Nicorette BucoMist should be avoided during breast-feeding, as nicotine passes into breast milk in amounts that may affect the baby. If your doctor has advised you to use Nicorette BucoMist while breast-feeding, the spray(s) should be administered immediately after breastfeeding and never within the two hours preceding breastfeeding.
Fertility
Smoking increases the risk of infertility in both women and men. The effect of nicotine on fertility is unknown.
Driving and use of machines
No effects on the ability to drive or operate machinery have been observed.
Nicorette BucoMist contains 12 mg of propylene glycol per spray. This medicine contains approximately 7 mg of alcohol (ethanol) in each spray, equivalent to 97 mg/ml. The amount of alcohol in each spray of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effect. This medicinal product also contains less than 1 mmol of sodium (23 mg) per spray, i.e., it is practically sodium-free. Due to the presence of butylated hydroxytoluene, Nicorette BucoMist may cause skin reactions (e.g., contact dermatitis) or irritation in the eyes or mucous membranes.
3. How to use Nicorette BucoMist
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Nicorette BucoMist must not be used in individuals under 18 years of age.
Consult your doctor if you have not managed to reduce the number of sprays or the number of cigarettes smoked after 6 weeks of treatment, or if you need to use Nicorette BucoMist for longer than 6 months. Nicorette BucoMist is usually used for 3 months. Nicorette BucoMist must not be used for longer than 6 months.
How you use Nicorette BucoMist depends on whether you are quitting smoking immediately or gradually reducing the number of cigarettes before quitting completely.
Quitting smoking immediately
The goal is to stop smoking immediately and use the spray to relieve nicotine cravings.
Do not use more than 2 sprays at a time or 4 sprays per hour over a 16-hour period. The maximum dose is 64 sprays during 16 hours in any 24-hour period.
Phase 1: Weeks 1-6 Use 1 or 2 sprays when cigarette cravings occur. If the craving is not controlled within a few minutes after one spray, use a second spray. If two sprays are needed, subsequent doses should also consist of two consecutive sprays. For most smokers, this means using 1 or 2 sprays every 30-60 minutes. Example: If you smoked an average of 15 cigarettes per day, you should use 1-2 sprays at least 15 times per day. Phase 2: Weeks 7-9 Begin reducing the number of daily sprays. By the end of week 9, you should be using HALF the number of sprays you used during Phase 1. Phase 3: Weeks 10-12 Continue reducing the number of sprays per day until you are using no more than 4 sprays per day by week 12. When you have reduced your usage to 2-4 sprays per day, you should stop using Nicorette BucoMist. |
Gradually quit smoking
The goal is to start gradually replacing some cigarettes with Nicorette BucoMist. Once this goal is achieved, stop smoking cigarettes completely and switch to using only the spray.
When you feel a strong urge to smoke, use 1–2 sprays of the spray instead of a cigarette to help control your cravings. The spray is intended to replace a cigarette—do not smoke shortly after using it. Using the spray without reducing the number of cigarettes smoked will make you feel sick (see section “If you use more Nicorette BucoMist than you should”). Reduce the number of cigarettes you smoke each day as much as possible, replacing them with sprays. As soon as you feel ready, you should stop smoking completely—no later than 12 weeks after starting treatment. After quitting smoking, gradually reduce the number of sprays per day. When you have reduced your use to 2–4 sprays per day, stop using Nicorette BucoMist altogether.
Do not use more than 2 sprays at once or 4 sprays per hour over a 16-hour period. The maximum dose is 64 sprays within any 16-hour period in a 24-hour day.
After completing treatment, you may again feel tempted to smoke. Keep the package with any unused doses of the medicine for situations in which a strong urge to smoke suddenly arises. You may use one spray, or two sprays if the first spray does not help within a few minutes.
Follow these instructions carefully and use the illustrations as a guide
Open the nozzle
How to open the dispenser
- Use your thumb to slide down the button (a) until it can be slightly pressed inward (b). Do not press too hard.
- While pressing the button, slide upward (c) to open the top of the dispenser.
How to prime the dispenser
When using Nicorette BucoMist for the first time, you must prime the spray pump. Point the nozzle toward a safe area where no other adults, children, or pets are present. Press down on the top of the dispenser with your index finger 3 times until a fine spray appears. If you do not use Nicorette BucoMist for two days, the priming procedure must be repeated.
How to use the dispenser
- Point the nozzle toward your open mouth as closely as possible.
- Press firmly on the top of the dispenser to release one spray into your mouth, avoiding the lips. Do not inhale while administering the spray to prevent it from entering your throat. For best results, do not swallow for several seconds after spraying.
To remove the nozzle
How to close the dispenser
- Slide down the button (d) until it can be pressed inward.
- While pressing, slide the top of the dispenser downward (f). Release the button. The dispenser is now closed.
To use another dose, repeat the steps described above.
Always close the dispenser after each use to prevent accidental use by children or unintended sprays. Be careful not to spray into your eyes during administration of Nicorette BucoMist. If the spray comes into contact with your eyes, rinse them thoroughly with water.
If you use more Nicorette BucoMist than you should
If you smoke while using Nicorette BucoMist, symptoms of nicotine overdose may occur.
If a child uses Nicorette BucoMist or if you use too many sprays, consult a doctor immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the product and the amount used. Doses tolerated by adults during treatment may cause severe poisoning symptoms in children and may even result in death.
Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache and dizziness, hearing disturbances, and a feeling of weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and generalized seizures.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Nicorette BucoMist may cause adverse effects, although not everyone experiences them.
Nicorette BucoMist may cause the same adverse effects as other forms of nicotine. These effects generally depend on the dose taken.
Effects related to quitting smoking (nicotine withdrawal)
Some of the unwanted effects experienced when quitting smoking may be withdrawal symptoms due to reduced nicotine intake.
These effects include:
- Irritability, aggression, impatience, or frustration.
- Feelings of anxiety, restlessness, or difficulty concentrating.
- Sleep disturbances.
- Increased appetite or weight gain.
- Lassitude.
- Craving for cigarettes (urges).
- Slowed heart rate.
- Gum bleeding or mouth ulcers.
- Dizziness or mild disorientation.
- Cough, sore throat, nasal congestion, or nasal discharge.
- Constipation.
If you experience any of the following rare adverse effects, stop using Nicorette BucoMist and consult your doctor immediately (signs of angioedema):
- Swelling of the face, tongue, or throat.
- Difficulty swallowing.
- Hives or difficulty breathing.
Very common: may affect more than 1 in 10 people:
- Hiccups (particularly common).
- Headache, nausea (feeling unwell).
- Throat irritation.
Common: may affect up to 1 in 10 people:
- Local reactions at the site of administration such as burning sensation, mouth inflammation, or changes in taste perception.
- Dry mouth or increased salivation.
- Indigestion-like sensation.
- Abdominal pain or discomfort.
- Vomiting, flatulence, or diarrhoea.
- Feeling of tiredness (fatigue).
- Hypersensitivity (allergy).
- Tingling.
Uncommon: may affect up to 1 in 100 people:
- Nasal effects such as nasal congestion or sneezing.
- Nasal discharge.
- Snoring (bronchospasm), or sensation of needing to breathe harder than normal (dyspnoea), throat tightness.
- Skin redness (flushing) or increased sweating.
- Mouth-related effects such as tingling, tongue swelling, mouth ulcers, damage to oral mucosa, changes in voice, mouth or throat pain, burping, gum bleeding.
- Palpitations (unusual awareness of heartbeat), increased heart rate, hypertension.
- Skin rash and/or itching (pruritus, urticaria).
- Abnormal dreams.
- Chest discomfort and pain.
- Feeling of weakness, feeling unwell.
Rare: may affect up to 1 in 1,000 people:
- Difficulty swallowing, numbness sensation in the mouth.
- Retching.
Frequency not known: frequency cannot be estimated from the available data:
- Blurred vision, increased tear production (lacrimation).
- Dry throat, stomach discomfort, lip pain.
- Abnormal heart rhythm.
- Skin redness.
- Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis).
- Seizures.
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Nicorette BucoMist
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the dispenser and packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment, particularly aquatic environments, in the case of nicotine.
6. Contents of the pack and other information
Composition of Nicorette BucoMist
- The active substance is nicotine. One spray delivers 1 mg of nicotine.
- The other components (excipients) are propylene glycol (E1520), anhydrous ethanol, tromethamine, poloxamer 407, glycerol (E422), sodium hydrogen carbonate, levomenthol, red fruit flavouring, refreshing flavour, sucralose, acesulfame potassium, butylated hydroxytoluene (E321), hydrochloric acid and purified water.
Appearance of the product and contents of the container
Nicorette BucoMist consists of a plastic bottle placed in a dispenser with a mechanical spray pump. The dispenser has a child-resistant safety system.
Each bottle contains 13.2 ml of solution, equivalent to 150 sprays.
Nicorette BucoMist is supplied in packs of 1, 2 or 3 dispensers.
Nicorette BucoMist is also available in packs of 1, 2 or 3 dispensers that include, beneath the back label, a Near Field Communication (NFC) chip enabling connectivity with the mobile application. These dispensers carry this icon
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
JNTL Consumer Health (Spain), S.L.
Paseo de las Doce Estrellas 5-7
28042 Madrid, Spain
Manufacturer:
McNeil AB,
P.O. Box 941, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden
or
Kenvue Belgium NV,
Michel De Braeystraat 52, 2000 Antwerpen, Belgium
This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:
Sweden | Nicorette Fruit Mint |
Austria | Nicorette Fruit & Mint Spray |
Belgium | Nicorette Fruit & Mint Mundspray/ |
Czech Republic | Nicorette Spray with forest fruit flavour |
Denmark | Nicorette QuickMist Cool Berry |
Finland | Nicorette Berrymint |
France | NICORETTE SPRAY® RED FRUITS |
Germany | Nicorette Fruit & Mint Spray |
Ireland | Nicorette QuickMist Cool Berry |
Luxembourg | Nicorette Fruit & Mint Buccal Spray |
Norway | Nicorette |
Poland | Nicorette Cool Berry |
Portugal | Nicorette Bucomist fruit mint flavour |
Slovakia | Nicorette Spray with forest fruit flavour |
Spain | Nicorette Bucomist fruit mint flavour |
Netherlands | Nicorette Fruit & Mint Mundspray |
Date of the last review of this leaflet: June 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es